Last updated: February 7, 2024
Sponsor: Centre Hospitalier Henri Laborit
Overall Status: Active - Recruiting
Phase
N/A
Condition
Suicide
Depression
Treatment
Transcranial direct current stimulation
Clinical Study ID
NCT06009523
2022-A01454-39
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age over 18 years
- Written informed consent
- Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
- Stable antidepressant treatment for 3 weeks
- MADRS score ≥ 20
- SSI score > 3
- Subject affiliated to a health insurance system
- Woman with effective contraception and agreeing to maintain it throughout the studyperiod.
Exclusion
Exclusion Criteria:
- Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis ofschizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
- Patient who has already undergone an electroconvulsive therapy course for the currentepisode and does not respond to this treatment
- Patient deprived of liberty
- Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization
- Contraindication to tDCS: intracerebral metallic implant (with the exception of dentalimplants), cardiac pacemaker, active or non-implanted devices in the region of thehead, acute eczema in the planned stimulation area
- Pregnant, parturient or breastfeeding woman
- Simultaneous participation in another interventional research
Study Design
Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Transcranial direct current stimulation
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
December 01, 2026
Study Description
Connect with a study center
Centre Hospitalier Nord-Deux-Sèvres
Faye-l'abbesse,
FranceActive - Recruiting
Centre Hospitalier Henri Laborit
Poitiers,
FranceActive - Recruiting
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